Cover ICH GCP principles (e.g., risk-based quality, 1.64), roles (4.1-4.13), informed consent (4.8), SAE reporting (4.11), and audit prep (5.19), plus ICMR specifics on equity and vulnerability (Sections 6-8).
8-16 hour sessions with lectures, case studies (e.g., deviation scenarios per NDCT Rule 22), role-plays, and quizzes; virtual/hybrid options for accessibility
Tailor to roles (e.g., nurse-focused on phlebotomy ethics); issue DCGI-recognized certificates valid for 3 years, with refresher modules annually.
Pre/post-assessments (target 80% pass rate); provide toolkits (SOP templates, checklists) and 3-month audits to measure impact.